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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: - followed recognized toxicology testing procedures - GLP compliant - study results copied without further assessment from the SIDS dossier

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987
Reference Type:
secondary source
Title:
SIDS INITIAL ASSESSMENT REPORT For SIAM 18 - 1,2,3-Trichloropropane
Author:
OECD
Year:
2004
Bibliographic source:
Published OECD SIDS initial assessments of HPV chemicals: http://www.oecd.org/document/63/0,3343,en_2649_34379_1897983_1_1_1_1,00.html

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to
Guideline:
other: FIFRA Pesticide Assessment Guidelines, Subdivision F, 81-3 (1982) and TSCA, Health Effects Test Guidelines, Acute inhalation Exposure.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2,3-trichloropropane
- Physical state: colorless liquid
- Analytical purity: 99.4 %
- Impurities (identity and concentrations): not reported in SIDS dossier study summary
- Lot/batch No.: not reported in SIDS dossier study summary
- Stability under test conditions: not reported, but expected to be stable
- Storage condition of test material: not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not reported in SIDS dossier study summary
- Age at study initiation: not reported in SIDS dossier study summary
- Weight at study initiation:males: 289 - 310 g; females: 167 - 176 g
- Fasting period before study: not reported in SIDS dossier study summary
- Housing: not reported in SIDS dossier study summary
- Diet (e.g. ad libitum): not reported in SIDS dossier study summary
- Water (e.g. ad libitum): not reported in SIDS dossier study summary
- Acclimation period: not reported in SIDS dossier study summary

ENVIRONMENTAL CONDITIONS
- not reported in SIDS dossier study summary

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
other: not clearly reported in SIDS dossier study summary, expected to be whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: New York University-style stainless steel chamber (300 L) with a pyramidal top and bottom.
- Exposure chamber volume: 300 L
- Method of holding animals in test chamber: not reported in SIDS dossier study summary
- Source and rate of air: Airflow rate was 63.9 L/min
- Method of conditioning air: not reported in SIDS dossier study summary
- System of generating vapor: liquid was metered to a Laskin-style nebulizer (sonic jet orifice) which generated the test atmosphere
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber: 26 °C; relative humidity: 35%; oxygen level: 21%.

TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography
- Samples taken from breathing zone: not reported in SIDS dossier study summary

Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
4 h
Concentrations:
4800 mg/m³
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pre exposure and at selected intervals post exposure
- Necropsy of survivors performed: yes
Statistics:
not reported in SIDS dossier study summary

Results and discussion

Preliminary study:
no
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4 800 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: limit test
Mortality:
- no mortality at the limit dose
Clinical signs:
- during exposure: hypoactivity, lacrimation and slow labored breathing;
- post exposure: periocular wetness, clear nasal discharge, hypoactivity, labored respiration, gasping, rattling sounds in lungs, red/brown
perinasal encrustation and ataxia.
Body weight:
- a slight body weight decrease was seen for the first 2 days post exposure.
Gross pathology:
- no adverse findings at necropsy

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute respiratory toxicity of 1,2,3-trichloropropane was tested in compliance with OECD TG 403 in Sprague-Dawley rats of both sexes at a limit dose of 4800 mg/m³ (exposure duration = 4 h). No fatalities occurred. Based on this result 1,2,3-trichloropropane should not be classified according to CLP.
Executive summary:

In the present study (Monsanto 1987) the acute respiratory toxicity of 1,2,3-trichloropropane was tested in compliance with OECD TG 403 in Sprague-Dawley rats of both sexes at a limit dose of 4800 mg/m³ (exposure duration = 4 h). No fatalities occurred. Based on this result 1,2,3-trichloropropane should not be classified according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.

Animals were probably whole body exposed in a New York University-style stainless steel chamber (temp.: 26 °C; relative humidity: 35%; oxygen level: 21%). Test item concentrations were analysed by gas chromatography. Animals were subsequently observed for clinical signs and body weight effects and sacrificed and necropsied 14 days after the exposure.

No fatalities occured at this limit dose, while during exposure hypoactivity, lacrimation and slow labored breathing was reported. Post exposure periocular wetness, clear nasal discharge, hypoactivity, labored respiration, gasping, rattling sounds in lungs, red/brown perinasal encrustation and ataxia were seen.At necropsy nevertheless no adverse effects were reported.